A Phase I Study of MEDI4736 in Patients with Advanced Solid Tumors

Protocol

12-179

Full Title

A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4736 in Subjects With Advanced Solid Tumors

Phase

I

Purpose

The purpose of this study is to find the highest dose of the investigational drug MEDI4736 which can be given safely in patients with advanced melanoma, renal cell cancer, colorectal cancer, or non-small cell lung cancer that is no longer responding to treatment. MEDI4736 is an antibody designed to boost the body’s immune system by targeting a protein on tumor cells called PD-L1.

PD-L1 normally maintains the balance of the immune system. In cancer, PD-L1 helps tumors evade detection and elimination by the immune system. MEDI4736 may increase the immune system’s ability to identify and destroy cancer cells. It is given intravenously (by vein).

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

Patients must have advanced melanoma, renal cell carcinoma, colorectal cancer, or non-small cell lung cancer that is no longer responding to treatment.

Any serious side effects of prior therapies must have resolved before the patient enters the study.

Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.

This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact the office of Dr. Neil H. Segal at 646-888-4187.

Clinical Trials

Clinical trials can offer you access to a new, experimental treatment before it is available to most patients. Joining a clinical trial is also a way to make a valuable contribution toward the fight against cancer.